Chemotherapy-induced thrombocytopenia
Conditions
Interventions
Control Group:No prophylactic medication
Intervention group:rhTPO + eltrombopag secondary prophylaxis
Sponsors
Ningbo Medical Centre Lihuili Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years, regardless of gender; 2. Histologically or cytologically confirmed solid tumor and undergoing chemotherapy (any regimen permitted); 3. Clinically defined as high risk for chemotherapy-induced thrombocytopenia (CTIT), meeting any one of the following high-risk criteria: (1) Previous occurrence of platelet count >=30×10^9/L and =50×10^9/L and =2; 6) Previous or ongoing radiotherapy, especially to long bones or flat bones (e.g., pelvis, sternum). 4. Baseline platelet count >=75×10^9/L and =1.5×10^9/L; hemoglobin (Hb) >=90 g/L; (2) Blood chemistry: Total bilirubin (TBIL) =60 mL/min; (3) Coagulation: International normalized ratio (INR) and activated partial thromboplastin time (APTT) =6 months; 7. Effective contraception used by fertile subjects (including female partners of male patients); negative pregnancy test for fertile female patients; 8. Voluntary participation in the study, signed written informed consent, good compliance, and willingness to comply with follow-up procedures.
Exclusion criteria
Exclusion criteria: 1. History of severe cerebrovascular disease (e.g., stroke, cerebrovascular accident) or severe cardiac disease (e.g., valvular heart disease, arrhythmia, myocardial infarction, congenital heart disease, cardiomyopathy, heart failure) within the past 3 months; 2. Thrombocytopenia not caused by chemotherapy within the past 6 months, including but not limited to primary immune thrombocytopenia (ITP), EDTA-dependent pseudothrombocytopenia, hypersplenism, etc.; 3. Complicated with hematological disorders such as aplastic anemia, myeloproliferative neoplasms, multiple myeloma, myelodysplastic syndromes (MDS), etc.; 4. Any arterial or venous thrombotic event within the past 6 months; 5. Received any of the following platelet-raising agents within 7 days prior to screening: (1) rhTPO, recombinant human interleukin-11 (rhIL-11); (2) thrombopoietin receptor agonists (e.g., eltrombopag, avatrombopag); (3) platelet-raising Chinese patent medicines (e.g., Compound Zaofan Wan, Sheng Xuexiaoban Jiaonang, Shenqi Fuzheng Keli, Danggui Buxue Koufuye, etc.); (4) caffeic acid tablets; 6. Platelet transfusion within 3 days prior to enrollment; 7. Known hypersensitivity to rhTPO or its excipients; 8. Presence of severe or uncontrolled infection (e.g., sepsis, severe pneumonia, pyogenic infection) or ongoing broad-spectrum antibiotic therapy for uncontrolled infection; 9. Subjects considered ineligible by the investigator (e.g., poor compliance, mental disorders, inability to comply with follow-up and study procedures, other serious comorbidities that may affect study outcomes).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of grade 2 or higher CTIT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and severity of bleeding events;Nadir and peak values of peripheral blood platelet count (×10?/L);Adverse events related to study drugs;Incidence of chemotherapy dose delays or reductions;Incidence of grade 3 or higher CTIT;Platelet transfusion rate, per-transfusion dose, and total transfusion dose;Duration of platelet count = 100×10?/L; | — |
Countries
China
Contacts
Public ContactYi Lu
Ningbo Medical Centre Lihuili Hospital
Outcome results
None listed